The Egyptian Association of Vascular Biology and Atherosclerosis (EAVA) Perspectives on the Usage of Inclisiran.

BACKGROUND: Elevation of low-density lipoprotein cholesterol (LDL-c) is still a hugely unmet need in the reduction of atherosclerotic cardiovascular disease. In the published CardioRisk project in Egypt, up to 71% of female participants had dyslipidemia. Control of LDL-c levels and thus improvement of hyperlipidemia is quite often very difficult. With the introduction of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, the decrease of significant cardiac adverse events, the patient control rate, and the death rate have all been improved. Inhibition of the formation of PCSK9 through inclisiran, which is a novel method of reducing LDL-c and is only given twice per year, seems alluring. After revision of published data, we analyzed the potential advantages of the use of inclisiran. CONCLUSION: The Egyptian Association for Vascular Biology and Atherosclerosis (EAVA) analyzed the data necessary for obtaining clear indications for the usage of inclisiran. We propose the addition of inclisiran to statins with or without ezetimibe for patients with documented atherosclerotic cardiovascular disease (ASCVD) or similar risk, familial hypercholesterolemia (FH) with another major risk factor, and very high and high risk diabetes mellitus, who did not reach LDL-c goals and/or with true statin intolerance. Inclisiran is also recommended as upfront therapy, with triple combination, in extreme risk subjects such as those with post acute coronary syndromes (ACS).

Egyptian Atherosclerosis and Vascular Biology Association Consensus on the Use of Sodium Glucose Cotransporter-2 Inhibitors in Heart Failure with Reduced Ejection Fraction.

Heart failure (HF) is a common cause of cardiovascular mortality and morbidity. Despite advances in treatment, the prognosis remains poor. Sodium-glucose co-transporter 2 (SGLT-2) inhibitors decrease HF events by 27-39% in high-risk patients with type 2 diabetes mellitus (T2DM). Moreover, the DAPA-HF and EMPEROR-Reduced studies randomized patients with HF with reduced ejection fraction (HFrEF) with or without diabetes mellitus to receive guideline-directed medical therapy versus guideline-directed medical therapy plus an SGLT-2 inhibitor. Both studies showed the benefits of SGLT-2 inhibitors. In addition, SGLT-2 inhibitors have shown improvement according to the EMPEROR-Preserved study of HF with preserved ejection fraction (HFpEF). Therefore, a panel of cardiology experts from the Egyptian Atherosclerosis and Vascular Biology Association (EAVA) revised the literature for SGLT-2 inhibitors in HF, along with the recommended indications and contraindications, and this article presents their consensus on the topic. The panel concluded that SGLT-2 inhibitors have significantly benefited patients with chronic HFrEF, as indicated through the DAPA-HF and EMPEROR-Reduced trials. The panel recommended early use of dapagliflozin 10 mg or empagliflozin 10 mg in patients with symptomatic chronic HFrEF, whether diabetic or non-diabetic, to ameliorate HF hospitalization rate, mortality, symptoms, and decline in renal function.

Safety and efficacy outcomes at 1 year after MitraClip therapy for percutaneous mitral valve repair in patients with severe mitral regurgitation: the Egyptian experience.

BACKGROUND: Our aim was to assess safety and efficacy outcomes at 1 year after MitraClip for percutaneous mitral valve repair in patients with severe mitral regurgitation. Twenty consecutive patients with significant MR (GIII or GIV) were selected according to the AHA/ACC guidelines from June 2016 to June 2019 and underwent percutaneous edge-to-edge mitral valve repair using MitraClip with a whole 1 year follow-up following the procedure. The primary acute safety endpoint was a 30-day freedom from any of the major adverse events (MAEs) or rehospitalization for heart failure. The primary efficacy endpoint was acute procedural success defined as clip implant with an improvement of MR to ≤ grade II, based on current guidelines, NYHA class, ejection fraction, and the left atrium size during follow-up. RESULTS: Mean age of the studied population was 66.8 ± 10 years and about 85% were males. All patients presented with NYHA > 2. EuroSCORE ranged between 7 and 15. Patients varied regarding their HAS-BLED score. None of them experienced MAEs at 30 days. Patients showed significant improvement of NHYA functional class, and all echocardiographic measurements such as left ventricular end systolic diameter, left ventricular end diastolic diameter, left ventricular ejection fraction, left atrium volume index and MR grade. They also showed significant improvement of right-side heart failure manifestations (lower limb edema, S3 gallop, neck veins congestion), and laboratory value (the mean Hb levels significantly increased from 11.96 ± 1.57 to 12.97 ± 1.36, while the median CRP significantly decreased from 7 (3-9) to 2 (1-3). As well, the median Pro-BNP significantly decreased from 89.5 (73-380) to 66.5 (53.5-151) following MV clipping. During the whole follow-up period, there was dramatic improvement in the NHYA functional class, echocardiographic assessment including left ventricular ejection fraction, and mitral regurge grade. During follow-up, four patients (20%) developed complications. There was no statistical difference between patients who developed complications and those who did not regarding their age (75.25 ± 12.42 versus 64.63 ± 9.21, respectively), BSA (1.69 ± 0.11 versus 1.79 ± 0.22, respectively), gender (75% versus 87.5% males respectively), MR etiology (75% versus 50% ischemic, 25% versus 50% non-ischemic), or NYHA pre- or post-mitral clipping. However, the median EuroSCORE was significantly higher in the complicated group (13, IQR= 11.5-14.5) than the non-complicated group (9.5, IQR=8.5-11.5). CONCLUSION: Percutaneous usage of MitraClip for mitral valve repair showed favorable reliability and better clinical outcomes. TRIAL REGISTRATION: ZU-IRB#2481-17-2-2016 Registered 17 February 2016, email: IRB_123@medicine.zu.edu.eg.

Egyptian Association of Vascular Biology and Atherosclerosis (EAVA) consensus on the usage of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors.

BACKGROUND: The current expert view of the PCSK9 inhibitors' use in Egypt is still ambiguous. MAIN BODY: Hyperlipidemia is an important, if not the most important, risk factor for the occurrence of atherosclerosis worldwide. Egypt is the most populous country in the Middle East and North Africa and has > 15% of the cardiovascular deaths in the region. The burden of dyslipidemia as seen in the recently published CardioRisk project conducted throughout Egypt shows a high prevalence of dyslipidemia as a risk factor that is still reaching up to 71% in female participants. Reaching the targets for LDL lowering, and thus control of hyperlipidemia, is quite often very difficult especially with the update of the last ESC guidelines. With the advent of PCSK9 inhibitors, the control rate of patients, reduction of cardiac major adverse events, and mortality have been improved. However, Egypt is not considered a rich country on the grounds of annual income, and this raises a concern on which patients would benefit from these expensive medications. Revising the randomized control trials, we analyzed the data that would enable us to control LDL in those patients, at risk, to obtain simple clear indications for the use of these rather expensive medications. CONCLUSION: We recommend the use of PCSK9 inhibitors in addition to statins ± ezetimibe in patients with ASCVD, by definition at very high risk; patients with ASCVD at very high risk who do not tolerate appropriate doses of at least three statins; and familial hypercholesterolaemia patients with clinically diagnosed ASCVD, at very high cardiovascular risk.

Prevalence of atherosclerosis risk factors in Egyptian patients with acute coronary syndrome: final data of the nationwide cross-sectional 'CardioRisk' project.

BACKGROUND: Little are known about the prevalence of atherosclerosis risk factors in Egyptian patients with acute coronary syndromes (ACS). OBJECTIVE: Describe the prevalence of these risk factors with focus on gender-specific data and patients with premature presentation. METHODS: From November 2015 to August 2018, data were collected from 3224 patients with ACS in 30 coronary care centers covering 11 governorates across Egypt, with focus premature ACS. RESULTS: The vast majority were males (74%) and the most prevalent age group was (56-65 years) representing 37% of whole study population. Among female patients, 92% were post-menopausal. The prevalence of premature ACS was 51%. Forty five percent of total males and 69.6% of total females with ACS had premature presentation (P<0.001). Abdominal obesity was the most prevalent risk factor (66%). Nearly half of the entire study patients were current smokers (48%). We showed a high prevalence of documented dyslipidemia (48%) as well. Early invasive management strategy was employed in 65% of patients with no significant gender disparity noticed. Vascular access for coronary angiography was most commonly femoral (80% of time). Emergent percutaneous coronary intervention (PCI) was attempted in 53% of patients. Thrombolytic therapy (using Streptokinase) was used in 24% of included participants. CONCLUSION: Among Egyptian patients with ACS, premature presentation is common with greater male preponderance. Abdominal obesity is the most prevalent risk factor followed by hypertension. Most traditional risk factors (apart from smoking) were more prevalent in women than men.

The pattern of risk-factor profile in Egyptian patients with acute coronary syndrome: phase II of the Egyptian cross-sectional CardioRisk project.

BACKGROUND: Egypt is the most populous country in the Middle East and North Africa and has more than 15% of the cardiovascular deaths in the region, but little is known about the prevalence of traditional risk factors and treatment strategies in acute coronary syndrome (ACS) patients across Egypt. METHODS: From November 2015 to August 2017, data were collected from 1 681 patients with ACS in 30 coronary care centres, covering 11 governorates across Egypt, spanning the Mediterranean coast, Nile Delta and Upper Egypt, with a focus on risk factors and management strategies. RESULTS: Women constituted 25% of the patients. Premature ACS was common, with 43% of men aged less than 55 years, and 67% of women under 65 years. Most men had ST-elevation myocardial infarction (STEMI) (49%), while a larger percentage of women had unstable angina and non-ST-elevation myocardial infarction (NSTEMI) (32% each; p < 0.001). Central obesity was present in 80% of men and 89% of women, with 32% of men and women having atherogenic dyslipidaemia. Current smoking was reported by 62% of men and by 72% of men under 55 years. A larger proportion of women had type 2 diabetes (53 vs 34% of men), hypertension (69 vs 49%), dyslipidaemia, and obesity (71 vs 41%) (p < 0.001 for all). There were no gender differences in most diagnostic and therapeutic procedures, but among STEMI patients, 51% of men underwent primary percutaneous coronary intervention compared to 46% of women (p = 0.064). CONCLUSIONS: Central obesity and smoking are extremely prevalent in Egypt, contributing to an increased burden of premature ACS, which warrants tailored prevention strategies. The recognised tendency worldwide to treat men more aggressively was less pronounced than expected.

Effects of exercise in combination with autologous bone marrow stem cell transplantation for patients with type 1 diabetes.

Stem cell therapy is a promising approach for the treatment of type 1 diabetes mellitus (T1D). Previous studies recommended regular exercise for the control of T1D. Experimental studies showed that a combination of stem cells and exercise yielded a better outcome. Yet, the effect of exercise programs following stem cell transplantation in patients with T1D has not been investigated. Thus, the current study aimed to examine the effect of a combined exercise program on measures of glycemic control in patients with T1D who received autologous bone marrow stem cell transplantation (ABMSCT). Thirty patients with controlled T1D were assigned into two equal groups. Both groups underwent ABMSCT and received insulin therapy and a diabetic diet regime. Only the exercise group followed the combined exercise program. Outcome measures of glycemic control (i.e. fasting blood glucose level [FBG], post-prandial blood glucose level [PPG], HbA1c, daily insulin dosage, and C-peptide levels) were tested before and after a 3-month rehabilitation period. There were significant (p < 0.05) decreases in all outcome measures except C-peptides after ABMSCT compared with before in both groups. Moreover, there was a significant decrease in the mean value of HbA1c in the exercise group compared with the control group after rehabilitation. Overall, this study strengthens the idea that adding exercise to ABMSCT is important to help control diabetes in patients with T1D.

Restenosis after percutaneous coronary intervention for coronary chronic total occlusion. The central role of an optimized immediate post-procedural angiographic result.

BACKGROUND: Factors of restenosis after percutaneous coronary intervention (PCI) for chronic total coronary occlusion (CTO) have not been fully explored. In particular, although the last ACC/AHA guidelines on PCI suggest that a minimum diameter stenosis of 10% with an optimal goal of as close to 0% as possible should be the new benchmark for lesions treated by stenting, angiographic success of PCI for CTO remains in the literature most often defined as a <30% residual diameter stenosis. Whether an optimized immediate post-PCI angiographic result (OAR) defined by a minimal diameter stenosis as close to 0% is associated with a lower restenosis rate in this subset of coronary lesions remains unknown. METHODS: Therefore, we assessed by quantitative coronary analysis (QCA) both the immediate post-PCI and 6-month follow-up angiographic results of 170 successfully treated true CTO. RESULTS: Post-PCI QCA immediate residual diameter stenosis was <30% in all 170 CTOs and OAR defined as a ≤10% residual stenosis was achieved in 133 (78%). Global binary restenosis rate was 21% in the 170 lesions. Restenosis rates were 46% and 14% in the non-OAR group and in the OAR group, respectively (p<0.0001). Multivariate analysis showed that a non-OAR, a younger age and a retrograde approach were independent factors of restenosis. CONCLUSION: Thus, an optimized immediate angiographic result with a minimal diameter stenosis as close to 0% as possible appears to be associated with a lower rate of restenosis after CTO PCI.

Usefulness of SYNTAX score II in complex percutaneous coronary interventions in the setting of acute coronary syndrome.

BACKGROUND: SYNTAX score II (SS II) integrates anatomical SS with clinical characteristics allowing an individualized prediction of long-term mortality. AIMS: We sought to assess to evaluate the usefulness of SS II in a real-world acute coronary syndromes (ACS) population with severe coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). METHODS: From August 2011 to May 2013, out of 1591 consecutive patients admitted for ACS, 217 (13.6%) showed severe CAD (three-vessel disease and/or left main involvement). Among the latter, 100 patients underwent PCI and were enrolled into the study. SS II was calculated in all patients. One-year clinical follow-up was performed; major adverse cardiac and cerebrovascular events (MACCE) were defined as a composite of death, nonfatal myocardial infarction, stroke, or repeat revascularization. RESULTS: The median SS II was 29 (range, 14-59). Overall, MACCE occurred in 25% of patients (cardiac death 4%, myocardial infarction 4%, stroke 0%, and repeat revascularization 17%). The 1-year MACCE-free survival was significantly lower in patients with SS (⩾29), than in those with SS II (<29) (64.2% vs. 87.2%, respectively; p = 0.007). In multivariate Cox regression analysis, the presence of unprotected left main stenosis [hazard ratio 2.52, 95% confidence interval (CI): 1.02-5.85; p = 0.031] and SS II ⩾29 (hazard ratio 2.74, 95% CI: 1.30-8.21; p = 0.011) were the only predictors of MACCE at 1-year clinical follow-up. The c-index of SS score II was 0.70 (95% CI: 0.58-0.81). For patients who experienced MACCE, the SS II reclassification improved by 36%, while in nonevent patients the reclassification improved by 22%. The net reclassification index was 0.24 (p = 0.09). CONCLUSION: SS II might represent a useful tool to predict clinical events in not only ideal stable patients, but also an unrestricted, real world population of patients with ACS and severe CAD undergoing PCI.

Transcarotid Transcatheter Aortic Valve Replacement: Feasibility and Safety.

OBJECTIVES: The purpose of this study was to assess the feasibility and safety of transcarotid transcatheter aortic valve replacement (TAVR). BACKGROUND: Many candidates for TAVR have challenging vascular anatomy that precludes transfemoral access. Transcarotid arterial access may be an option for such patients. METHODS: The French Transcarotid TAVR Registry is a voluntary database that prospectively collected patient demographics, procedural characteristics, and clinical outcomes among patients undergoing transcarotid TAVR. Outcomes are reported according to the updated Valve Academic Research Consortium criteria. RESULTS: Among 96 patients undergoing transcarotid TAVR at 3 French sites (2009 to 2013), the mean age and Society of Thoracic Surgeons predicted risk of mortality were 79.4 ± 9.2 years and 7.1 ± 4.1%, respectively. Successful carotid artery access was achieved in all patients. The Medtronic CoreValve (Medtronic, Inc., Minneapolis, Minnesota) (n = 89; 92.7%) and Edwards SAPIEN valves (Edwards Lifesciences, Irvine, California) (n = 7; 7.3%) were used. Procedural complications included: valve embolization (3.1%), requirement for a second valve (3.1%), and tamponade (4.2%). There were no major bleeds or major vascular complications related to the access site. There were 3 (3.1%) procedural deaths and 6 (6.3%) deaths at 30 days. The 1-year mortality rate was 16.7%. There were 3 (3.1%) cases of Valve Academic Research Consortium-defined in-hospital stroke (n = 0) or transient ischemic attack (TIA) (n = 3). None of these patients achieved the criteria for stroke and none manifested new ischemic lesions on cerebral computed tomography or magnetic resonance imaging. At 30 days, a further 3 TIAs were observed, giving an overall stroke/TIA rate of 6.3%. CONCLUSIONS: Transcarotid vascular access for TAVR is feasible and is associated with encouraging short- and medium-term clinical outcomes. Prospective studies are required to ascertain if transcarotid TAVR yields equivalent results to other nonfemoral vascular access routes.

Incidence, treatment, and in-hospital outcome of bifurcation lesions in patients undergoing percutaneous coronary interventions for chronic total occlusions.

BACKGROUND: Bifurcation lesions represent a distinct lesion subset associated with an increased risk of procedural complications. Data on the incidence, treatment, and outcome of bifurcation lesions associated with chronic total occlusions are limited. METHODS: Among chronic total occlusion procedures performed by a single experienced operator, patients with a bifurcation lesion within the chronic total occlusion vessel and a side branch reference diameter greater than or equal to 2.0 mm were enrolled. RESULTS: A total of 905 patients (mean age 61.1±9.5 years, men 89.4%) were treated for 922 chronic total occlusion lesions. Among these, 244 bifurcation lesions were observed (26.5%). The procedural time was significantly longer in bifurcation lesions (139±67 vs. 124±68 min; P=0.003), with greater use of contrast load (470±193 vs. 436±227 ml; P=0.04) and higher number of stents (3.1±1.5 vs. 2.9±1.4; P=0.035). Overall, an angiographic success was achieved in 91.1% of cases with a higher rate in nonbifurcation lesions (92.5 vs. 87.3%; P=0.04). Coronary perforations were more often observed in bifurcation lesions (4.9 vs. 1.7%; P<0.001), resulting in more tamponades (2.4 vs. 0.2%; P<0.001). True bifurcations were encountered in the majority of cases (86.8%) and required more two-stent techniques than false bifurcations (50 vs. 18.8%; P=0.001). CONCLUSION: The incidence of bifurcation lesions in chronic total occlusions is higher than that reported in continuous lesions. The presence of a bifurcation lesion increases the complexity of the procedure and may lead to less angiographic success and more periprocedural complications.

Long-term clinical and angiographic outcomes of the mini-STAR technique as a bailout strategy for percutaneous coronary intervention of chronic total occlusion.

BACKGROUND: A promising variant of the subintimal tracking and re-entry (STAR) technique, called "mini-STAR," has been recently described as a successful rescue technique after revascularization failure by conventional techniques for coronary chronic total occlusion (CTO). METHODS: The current study enrolled patients with CTO who underwent successful revascularization by the mini-STAR technique as a bailout strategy. Two-year clinical follow-up and angiographic control procedures were performed. RESULTS: From March 2009-September 2011, 100 of 117 patients (mean age, 61.4 ± 10.9 years) underwent successful recanalization of CTO by the mini-STAR technique as a bailout strategy. Drug-eluting stents (DESs) were implanted in all cases. At 2-year follow-up, the major adverse cardiac events (MACE)-free survival was 89.2%, with a target lesion revascularization (TLR) rate of 6.5%. Angiographic follow-up was performed in 72% of patients. CTO target lesion restenosis was observed in 25% of patients, whereas the reocclusion rate was 12.5%. At multivariate Cox analysis, final thrombolysis in myocardial infarction (TIMI) flow < grade 3 was related to occurrence of MACE (hazard ratio, 5.9; 95% confidence interval [CI], 1.4-24.4; P = 0.013). Final TIMI flow < grade 3 (odds ratio [OR], 5.41; 95% CI, 1.05-27.73; P = 0.043) and CTO stent length (OR, 0.96; 95% CI, 0.93-0.99; P = 0.017) were independent predictors of reocclusion. The independent variables related to restenosis were first-generation DESs (OR, 4.10; 95% CI, 1.23-13.64; P = 0.022) and CTO stent length (OR, 0.97; 95% CI, 0.95-0.99; P = 0.027). CONCLUSIONS: As bailout strategy for CTO revascularization, the mini-STAR technique shows low MACE and TLR rates at long-term follow-up.

Renal sympathetic denervation for treatment of resistant hypertension: Egyptian experience.

BACKGROUND: Among the Egyptian population with essential hypertension, a minority are under control (systolic pressure <140 mmHg and diastolic pressure <90 mmHg), despite the use of multiple antihypertensive medications. In this article, we describe our experience with percutaneous treatment using renal artery radiofrequency (RF) ablation. OBJECTIVES: To evaluate the feasibility, efficacy, and safety of catheter-based radiofrequency renal sympathetic denervation for treatment of resistant hypertension in Egyptian patients. METHODS: Patients with essential hypertension unresponsive to at least 3 types of antihypertensive medical therapy (baseline office systolic blood pressure ≥160 mmHg) (n = 55) were enrolled between February 2012 and June 2013 and received percutaneous RF ablation. Patients were followed up for 6 months after treatment to detect any change in office-based measurement of blood pressure. Urine and blood samples were taken to evaluate the effects on renal function. RESULTS: A reduction of mean office blood pressure was seen from 174/103 ± 9/5 mmHg at baseline to 150/91 ± 8/5 mmHg at 6 months follow-up (P = 0.001). Also, we noted a significant decrease in plasma renin activity (3.66 ± 0.64 vs. 3.37 ± 0.47 ng/mL per hour; P = 0.003), and there were no periprocedural complications, no adverse events, and no change in renal function during the follow-up period. Also, no change was noted in the number of medications after 6 months (3.95 ± 1.64 vs. 3.67 ± 0.72; P = 0.27). CONCLUSION: In this observational study, catheter-based renal denervation causes sustained blood pressure reduction in patients with resistant hypertension, without serious adverse events.

Long-term clinical outcome and routine angiographic follow-up after successful recanalization of complex coronary true chronic total occlusion with a long stent length: a single-center experience.

OBJECTIVES: To evaluate clinical and angiographic outcomes after successful recanalization of chronic total coronary occlusion (CTO) with implantation of a long total stent length (SL). BACKGROUND: Routine follow-up angiogram (RFUA) data after successful recanalization of CTO with a long SL are lacking. METHODS: RFUAs were performed at 6 months after successful recanalization of 106 CTOs using drug-eluting stents (DESs) with a long SL (≥ 20 mm) in 102 consecutive patients. RESULTS: Mean number of stents was 3.9 ± 1.8 and mean total SL was 78 ± 32 mm (range, 23-174 mm). Sirolimus-eluting stents (SESs) were used in 100 lesions. In-stent total reocclusion occurred in 2 cases (1 SES and 1 non-SES DES). Restenosis rate was 18% in the 100 SES subgroup (total SL, 79 ± 33 mm; range, 23-174 mm; mean number of stents, 3.9 ± 1.8); younger age and longer total SL were found to be independent predictors of restenosis (longer age: hazard ratio, 0.939; 95% confidence interval, 0.885-0.996; P=.035; longer total SL: hazard ratio, 1.017; 95% confidence interval, 1.00-1.03; P=.045). Restenosis type was diffuse in only 11% and 89% were successfully treated by repeat percutaneous coronary intervention. During a median follow-up of 2 years (interquartile range, 1-4.3 years), major cardiac events other than those angiographically driven at RFUA occurred in 2 patients. CONCLUSION: Angiographic restenosis rate remains acceptable in patients with complex CTO successfully treated by DES despite a long SL.

Immediate and long-term results of a modified simultaneous kissing stenting for percutaneous coronary intervention of coronary artery bifurcation lesions.

OBJECTIVES: We propose a modified simultaneous kissing stenting technique (MSKS) based on systematic implantation of a protective stent in the proximal main vessel (PMV) proximally to the bifurcation before simultaneous kissing stenting (SKS). BACKGROUND: SKS has been proposed in large-size coronary vessel bifurcation lesions (BLs) when the PMV can accommodate two stents. SKS implies, however, low-pressure simultaneous final balloon inflations to avoid retrograde PMV dissection or rupture and therefore may not ensure optimal final stent apposition. METHODS: From January 2005 to May 2008, a total of 97 patients with 100 BLs (true bifurcation in 92%) who underwent MSKS were enrolled in a prospective registry. Drug-eluting stents were used for distal main vessel and side branch. Drug-eluting or large-size bare-metal stents were used as proximal protective stents. RESULTS: Immediate procedural success rate was 100%. Global restenosis rate was 10% (5% in the main vessel and 8% in the side branch) at follow-up angiogram performed at 7 months in all patients (100%). No patient had early or late stent thrombosis. Two cases of non-fatal very late stent thrombosis occurred at 46 and 64 months. Over a mean 4.5-year follow-up period, target lesion revascularization rate was 11%, with only 3% driven by clinical ischemia. CONCLUSION: Protective stent systematic implantation in the PMV represents a newly modified SKS technique that allows safe finalization of the procedure by high-pressure kissing balloon final inflation, ensuring optimal stent apposition with high immediate procedural success and low rates of long-term events.

Simultaneous dual vascular access site for the treatment of coronary artery bifurcation lesions by complex 2-stent technique.

OBJECTIVES: To propose an original approach based on simultaneous dual vascular access site (DAS) using 2 small-size guiding catheters to easily perform complex 2-stent techniques for bifurcation coronary lesions (BL). BACKGROUND: Simultaneous kissing stenting and classic crush technique require large 7 or 8Fr guiding catheters leading to large amounts of contrast medium, vascular access site complications, and sometimes frictions or criss-cross of the 2-stent delivery systems. METHODS: DAS was used in 30 patients with BL (11 radio-radial, 16 radio-femoral, and 3 femoro-femoral). Among 60 guiding catheters, the size was 5Fr in 28, 6Fr in 30, and 7Fr in 2 cases of double adjacent BL. When 2 different size catheters were used, contrast medium injections were done using the smallest size catheter. DAS patients were compared with a group of 30 BL patients treated using a single femoral vascular access site (SAS) with 7 or 8Fr catheters. RESULTS: Success rate was 100% in all patients. Contrast volume used was smaller in DAS than in SAS patients (277 ± 156 cc vs. 380 ± 165 cc,P = 0.01). No vascular access site complication occurred in the sub-group of the 11 DAS radio-radial patients. Postintervention hospitalization duration was shorter in DAS than in SAS (1.9 ± 2 vs. 2.8 ± 2 days,P = 0.048). CONCLUSION: DAS allows to successfully perform complex stenting technique of BL using small-size guiding catheters leading to decreased contrast medium volume, decreased vascular access site complications rates, and shortened hospitalization duration.

Return to work after acute ST-segment elevation myocardial infarction in the modern era of reperfusion by direct percutaneous coronary intervention.

BACKGROUND: Previous studies have evaluated return to work after acute ST-segment elevation myocardial infarction (STEMI) treated medically, after bypass surgery or after percutaneous coronary intervention (PCI) for stable coronary artery disease. However, there are few data regarding return to work after acute STEMI treated by direct PCI. AIMS: To analyse the factors influencing return to work after STEMI treated by direct PCI. METHODS: Two hundred consecutive patients who underwent direct PCI for acute STEMI and who were employed at the time of their STEMI were studied. Stents were used in 94% of patients and glycoprotein IIb/IIIa inhibitors in 77%. RESULTS: Among the 200 patients, 152 (76%) patients returned to work and 48 (24%) did not. Patients who did not return to work did not differ from those who returned to work in terms of time from onset of chest pain to PCI, STEMI location, left ventricular function, extent of vessel disease, PCI technique and success, completeness of revascularization, duration of hospital stay, intrahospital complications and performance of cardiac rehabilitation. Multivariable analysis showed that older age, daytime onset of chest pain, manual labour, rapid call-out of the emergency medical team, unmarried status and a limited number of risk factors were independent predictors of non-return to work. CONCLUSION: Age, sociopsychological and occupational factors appear to be the strongest predictors of return to work after STEMI treated by direct PCI. Clinical and procedural factors as well as cardiac rehabilitation appear to have no impact on return to work in this subset of patients.

Cutting balloon angioplasty in percutaneous carotid interventions.

PURPOSE: To report a prospective feasibility study of cutting balloon angioplasty (CBA) applied in the predilation phase of carotid artery stenting (CAS) in highly calcified lesions. METHODS: From January 2003 to February 2007, 178 consecutive patients (109 men; mean age 73.1+/-7.3 years) with highly calcified carotid lesions underwent CAS with CBA applied as a pre-specified strategy in the predilation phase of the procedure. All steps in the procedure were performed under cerebral filter protection. The cutting balloon ranged in diameter from 3 to 4 mm and was inflated at nominal pressures in the target lesion. Pre-CBA dilation with a low-profile coronary balloon was performed only when the cutting balloon was not able to cross the lesion. Selection of the filters and stents was at the operator's discretion. Primary endpoints were the all stroke and death rates at 30 days and 6 months. Secondary endpoints included cutting balloon success (positioning and full balloon inflation), CAS technical success (residual angiographic stenosis <30%), CAS procedural success (technical success and no complications), and in-hospital major complications. RESULTS: Cutting balloon success was achieved in all 178 patients. In 32 (18.0%), pre-CBA dilation was necessary due to inability to cross the lesion with the cutting balloon initially. CAS technical success was achieved in all patients. One (0.6%) patient suffered transient neurological intolerance due to flow cessation from massive debris in the distal filter; this event was completely resolved after the filter was removed (CAS procedural success 99.4%). One patient suffered a major stroke at day 15 (0.6% 30-day all stroke and death rate). At the 6-month follow-up, 174 (97.7%) patients were evaluated; 1 patient died from myocardial infarction at day 35, and 2 patients died from non-neurological or cardiac causes at days 103 and 158. The cumulative all stroke and death rate was 2.2%. CONCLUSION: These data suggest that CBA performed during the predilation phase of CAS in highly calcified lesion is a safe and useful method to prepare this lesion subset for stenting.